Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071846
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROGLYCERIN IN DEXTROSE 5% NITROGLYCERIN 10MG/100ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/31/1990 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2007 SUPPL-26 Labeling

Label is not available on this site.

05/31/2001 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/31/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/2001 SUPPL-20 Labeling

Label is not available on this site.

05/31/2001 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/2000 SUPPL-17 Labeling

Label is not available on this site.

02/06/2001 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/06/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/06/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/24/1996 SUPPL-10 Labeling

Label is not available on this site.

11/02/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/14/1996 SUPPL-6 Labeling

Label is not available on this site.

09/09/1992 SUPPL-5 Labeling

Label is not available on this site.

07/16/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/16/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/16/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/16/1993 SUPPL-1 Labeling

Label is not available on this site.

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